Kornimate/medical-research-clean huggingface dataset:
treatment with 5-aminolevulinic acid before cardiac surgery

Conditions: Cardiac Surgical Procedures; Coronary Artery Bypass; Aortic Valve Disease; Mitral Valve Disease

Summary: talen is a prospective randomised double-blind placebo-controlled phase 2 study of 5-aminolevulinic acid with sodium ferrous citrate (5-ala-sfc) in adult patients undergoing cardiac surgery on cardiopulmonary bypass (cpb). talen aims to identify the optimal biological dose (obd) of 5-ala-sfc.

talen is a prospective, randomised, double blind, placebo-controlled phase 2 study of 5-ala-sfc administration in adults undergoing non-emergent cardiac surgery on cpb examining the potential of 5-ala-sfc to induce haem oxygenase-1 (ho-1) as a novel cardio- and cyto-protective strategy for clinical benefit. 5-ala is an amino acid found in several foods and a natural endogenous precursor in the synthesis of haem. oral administration of 5-ala-sfc has been shown to be safe and to induce a pharmacodynamic effect on the key effector, ho-1. talen is designed as a dose-finding trial with sequential dose cohorts, evaluating the safety, tolerability and pd response to 5-ala-sfc to determine the optimum biological dose for further evaluation.

Eligibility criteria:
inclusion criteria: * scheduled for non-emergent cardiac surgery under cpb (including coronary artery bypass grafting, valve replacement, valve repair or a combination thereof) * signed informed consent * age ≥18 years * able and willing to comply with all study requirements exclusion criteria: * female participants who are of childbearing potential who are either unable or unwilling to use highly effective contraception, or who are pregnant or breast feeding * history of hypersensitivity to 5-ala, sfc and/or porphyrins * acute or chronic types of porphyria * known genetic haemochromatosis or clinically significant iron overload * history of clinically significant photosensitization * current long-term (\> 3 months) use of amiodarone * concomitant use of hypericin extract (including st john's wort) or concomitant therapeutic dose oral iron replacement * use of other investigational medical product(s) \< 28 days prior to study or 5 half-lives, whichever is longer * cardiogenic shock/low cardiac output syndrome requiring catecholamine infusion and/or mechanical circulatory support prior to induction of anaesthesia for cardiac surgery * recent acute myocardial infarction * cardiac surgery without cardiopulmonary bypass or induced fibrillating heart surgery * inadequate renal or liver function * any other condition which, in the opinion of the investigator, makes the patient unsuitable for or may compromise their participation in the study

Keywords: heme oxygenase cardiopulmonary bypass ho-1 aortic valve replacement mitral valve surgery 5-aminolevulinic acid delta aminolevulinic acid sodium ferrous citrate
sars-cov-2 transmission in belgian primary schools of the federation wallonia - brussels: an epidemiological pilot study

Conditions: SARS-CoV-2 Infection

Summary: the investigators hypothesize that children are less likely to become infected in the school environment, compared to the household or outside the school setting. primary schools do not play a major role in sars-cov-2 spreading. they hypothesize that incidence level in schools is mainly a consequence of community transmission. the incidence level in household and that the secondary attack rate in schools remains at least 5 times lower that the transmission level in households.


Eligibility criteria:
inclusion criteria: * all children and school attenders from selected schools was invited to participate exclusion criteria: * refusal to provide written informed consent before enrolment

Keywords: primary schools
evaluating muscle function after ankle surgery

Conditions: Muscle Atrophy; Muscle Weakness; Fractures

Summary: patients who are forced to rest or reduce activity as a result of illness, injury, or surgery often experience resulting muscle weakness. this study will evaluate muscle features and muscle strength in patients who are recovering from surgery for broken ankles. the goal of this study is to improve the recovery of muscle function and overall ability after prolonged periods of ankle inactivity due to surgery.

many physiological conditions are associated with muscle weakness and can affect movement. this study will investigate which metabolic and morphological features of skeletal muscle are uniquely altered during the course of rehabilitation and how they affect muscle function and performance in daily ambulatory activities. this study will also examine how well the commonly used assessment measures reflect actual muscle capacity. finally, because there is evidence that activity does not affect all fiber types uniformly, fiber-type specific metabolic and morphological measures will be performed. participants in this study will have had an ankle injury that has been treated surgically (open reduction internal fixation, or orif) followed by 5 to 10 weeks of cast immobilization. following initial baseline measurements made after 1 week of re-ambulation, participants are enrolled in a 10-week rehabilitation program that focuses on restoration of both muscle strength and endurance. assessments are made at weeks 5 and 10 and include 31p-magnetic resonance spectroscopy (mrs), magnetic resonance imaging (mri), muscle biopsy, and muscle function and functional performance tests. 31p-measurements monitor changes in the in vivo metabolic characteristics of skeletal muscle. 3d-mri procedures will be used to quantify the maximal muscle cross-sectional area and total muscle volume. muscle endurance and strength will be measured using an isokinetic dynamometer. functional performance tests consist of self-selected walking pace, power for ascending and descending stairs, and toe raises while standing on one foot. nine participants (six patients and three control volunteers) will be studied each year. control volunteers are submitted to the same measurements at similar time intervals in order to assess variability over time.

Eligibility criteria:
inclusion criteria: * 5 to 10 weeks of cast immobilization following surgery (orif) for mallerolar fracture exclusion criteria: * pregnant or breastfeeding * severe claustrophobia * mri incompatible metal implants (e.g., pacemaker) * diabetes or peripheral neuropathies * bleeding disorders

Keywords: disuse atrophy ankle fracture exercise, therapy cast immobilization deconditioning sarcopenia
effects of a peri-operative brief mindfulness-based intervention on post-operative pain and disability

Conditions: Chronic Hip Pain; Worries; Pain or Disability; Quality of Life

Summary: this study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty. all participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety. the half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan.

psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health, leading to significantly reduced quality of life. it has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery. pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed. mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population. with the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty, this pilot study has been developed to demonstrate proof of concept, test/refine the intervention, recruitment, and data collection procedures, and test the intervention's acceptability in the peri-operative setting.

Eligibility criteria:
inclusion criteria: * adult (age 18+) patients presenting at the pre-admission unit (pau) at the general campus of the ottawa hospital (toh) for total hip arthroplasty (tha) * history of pain for ≥3 months (chronic pain) * anxiety scores of ≥8 on the generalized anxiety disorder 7-item (gad-7) scale * ability to understand oral and written english or french exclusion criteria: * refusal or inability to provide consent * severe depressive symptoms as indicated by score ≥ 20 on the patient health questionnaire (phq-9) scale * prior mindfulness training experience * pre-planned same day discharge after surgery

Keywords: mindfulness chronic pain chronic hip pain total hip arthroplasty disability quality of life
secondary prevention of vte in patients with cancer and catheter-related upper extremity deep vein thrombosis

Conditions: Venous Thromboembolism; Cancer; Upper Extremity Deep Vein Thrombosis; Catheter-Related Infections

Summary: this trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (dvt).

the aim of the stream-line trial is to demonstrate that the stream-line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity dvt. upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter (cvc) or active cancer is present (stream-line management strategy). apixaban will be stopped at the time of cvc removal and when cancer is in remission. day 90±14 and day 180+14 follow-up visit procedures will be done by phone call or in person.

Eligibility criteria:
inclusion criteria: 1. adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission. 2. objectively confirmed catheter-related upper extremity dvt and treated with any standard therapeutic anticoagulation (including lmwh dose reduction to 75% after the first month) for at least 3 months. 3. able and willing to provide informed consent. exclusion criteria: 1. active bleeding or other reasons for which anticoagulation is contraindicated. 2. other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.). 3. anticoagulation has been permanently stopped or reduced to prophylactic dose prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days . 4. known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy. 5. concomitant use of strong inhibitors or inducers of both cytochrome p450 3a4 (enzyme) and p-glycoprotein.
association of inspiratory muscle training with hd-tdcs for assistance to patients with long covid-19

Conditions: Coronavirus; Inspiratory Muscle Training; Respiratory Infection; COVID-19

Summary: covid-19 is an infectious disease which presents a heterogenous clinical presentation. recent investigations suggest that people who were infected by covid-19 often develop physical disabilities (i.e. pain, fatigue), neurological complications and and mainly disorders of the respiratory system, such as respiratory muscle weakness after hospital discharge. many therapeutic approaches such as transcranial direct current stimulation (tdcs) have been proposed to minimize functional and structural impairments. the aim of the present study is to evaluate the effects of inspiratory muscle training associated with stimulation of the diaphragmatic motor cortex through hd-tdcs in post-covid-19 patients on inspiratory muscle strength, pulmonary function, inflammatory levels and functional capacity.


Eligibility criteria:
inclusion criteria: * patients who had a medical diagnosis of covid-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled. exclusion criteria: * those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.

Keywords: transcranial direct current stimulation non-invasive brain stimulation inspiratory muscle training functional capacity maximal inspiratory pressure
the effect of mixed exercise and metabolic stress in relationship to age in healthy men

Conditions: Healthy

Summary: aging in men reduces the amount of luteinizing hormone (lh) and testosterone (te) secreted in each burst. stress-associated mechanisms introduced by acute illness and chronic disease decrease lh and te secretion further. a major unresolved issue is whether the aging process heightens the negative effects of a stressor (whether physical or metabolic) upon lh and te secretion. this study will assess lh and te secretion in response to a physical stressor (maximal exercise) and a common metabolic stressor (hyperglycemia) as a function of age in healthy men ages 18-80 yr.


Eligibility criteria:
inclusion criteria: * community dwelling, healthy men age 18 to 80 * body-mass index (bmi) 18-30 kg/m2 * willingness to provide written informed consent * physician acceptable screening ecg for participants 60 years and older exclusion criteria: * recent use of psychotropic or neuroactive drugs (within five biological half-live) * obesity (outside weight range above) * acute weight change (loss or gain of \>2 kg in 6 weeks * laboratory test results not deemed physician acceptable * triglycerides \> 300 * bun \>30 * creatinine \> 1.5 mg/dl * liver functions tests twice upper limit of normal * electrolyte abnormality * anemia; hemoglobin \< 12.0 gm/dl * drug or alcohol abuse * psychosis, depression, mania or severe anxiety * acute or chronic organ-system disease * endocrinopathy, other than primary thyroidal failure receiving replacement * untreated osteoporosis * nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission) * psa \> 4.0 ng/ml, history or suspicion of prostatic disease (elevated psa,indeterminate nodule or mass, obstructive uropathy) * history of carcinoma (excluding localized basal cell carcinoma removed or surgically treated with no recurrence * history of thrombotic arterial disease (stroke, tia, mi, angina) or deep vein thrombophlebitis * history of chf, cardiac arrhythmias, congential qt prolongation, and medications used to treat cardiac arrhythmias * gynecomastia \> 2 cm, untreated * untreated gallbladder disease * history of smoking greater than one ppd.

Keywords: healthy male
effect of arm ergometry on children with down syndrome

Conditions: EFFECT OF ARM ERGOMETRY ON RESPIRATION

Summary: cardiopulmonary issues are the major cause of sickness and hospitalisation in children with down syndrome . down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis.

30 down's syndrome children (boys and girls). randomly separated into two groups of equal size. both groups received traditional chest physical therapy, with the addition of arm ergometry training in group b

Eligibility criteria:
inclusion criteria: * comprehend and follow directions * age 10-14 exclusion criteria: anomalies of the vasculature. -participating in sports of any kind. moderate to severe asthma
study of safety and efficacy of pf-04991532 in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: b2611003 is designed to study how safe and effective an investigational medication (pf-04991532) is in people with type 2 diabetes. subjects in the study will receive 1 of 6 treatments for 3 months. one of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.


Eligibility criteria:
inclusion criteria: subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2 exclusion criteria: subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pressure, significant kidney disease.

Keywords: phase 2 safety and efficacy study with pf-04991532 type 2 diabetes
a phase 2, randomized, double blind, placebo controlled study of amg 386 in combination with folfiri in subjects with previously treated metastatic colorectal carcinoma

Conditions: Cancer; Carcinoma; Colon Cancer; Colorectal Cancer; Gastrointestinal Cancer; Metastases; Metastatic Cancer; Metastatic Colorectal Cancer; Oncology; Rectal Cancer

Summary: this clinical trial will compare the efficacy and safety of the combination of amg 386 and folfiri with folfiri alone in second line treatment of metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease * one and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted * at least one uni dimensionally measurable lesion per modified recist criteria. all sites of disease must be evaluated \<= 28 days before randomization * radiographically documented disease progression per modified recist criteria either while receiving or \<= 6 months after the last dose of prior chemotherapy regimen for metastatic disease * ecog performance status of 0 or 1 * man or woman \>= 18 years of age * adequate end organ assessments by laboratory studies (hematological and chemistries) * life expectancy \>= 3 months exclusion criteria: * exclude subjects with a history of prior malignancy, except: * malignancy treated with curative intent and with no known active disease present for \>= 3 years before enrollment and felt to be at low risk for recurrence by treating physician * adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease * adequately treated cervical carcinoma in situ without evidence of disease * prostatic intraepithelial neoplasia without evidence of prostate cancer * prior irinotecan therapy * systemic chemotherapy, hormonal therapy, or immunotherapy \<= 21 days prior to randomization * experimental or approved proteins/antibodies (eg, bevacizumab) \<= 30 days prior to randomization * clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent * known allergy or hypersensitivity to irinotecan, 5 fu (known dihydropyrimidine dehydrogenase deficiency) or leucovorin * active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \>= ctc grade 2 \[ctcae version 3.0\])

Keywords: metastatic colorectal cancer colorectal cancer colon cancer
study comparing quantitative assessments in open-angle glaucoma (oag) and/or ocular hypertension (oht)

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will evaluate assessments from the goniometric lens compared with those from anterior segment imaging in patients with open-angle glaucoma (oag) and/or ocular hypertension (oht).


Eligibility criteria:
inclusion criteria: * open-angle glaucoma or ocular hypertension exclusion criteria: * allergy or sensitivity to diagnostic agents used in study
comparison of two different ncpap methods in preterm infants with respiratory distress syndrome

Conditions: Ventilatory Failure

Summary: is to compare introduction of two different ncpap methods in terms of mechanical ventilation (mv) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with respiratory distress syndrome (rds) at 26-30 weeks of gestation.

study design ncpap support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (sle; infant flow system, viasys corp., usa) and infant flow-driver device (sle; the respiratory parameter settings were a peep of 5-8 cmh2o. cpap was stopped when peep 5 cmh2o and infants showed no signs of rds with fio2 \<0.30. under non-invasive respiratory support, in case of fio2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. the second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of fio2 need is ≥ 0.30. non-invasive respiratory support failure is set as follows: * fio2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher, * apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation, * persistent acidosis; presence of ph \ 65 mmhg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis, * severe respiratory distress, * pulmonary haemorrhage and cardiopulmonary arrest.

Eligibility criteria:
inclusion criteria: * preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with rds signs will be included exclusion criteria: * major congenital anomalies * presence of cardiovascular instability * intubation at admission to the nicu * consent not provided or refused

Keywords: ncpap respiratory distress syndrome
phase i study to evaluate kp405 in healthy and parkinson's disease patients

Conditions: Safety Issues; Tolerance

Summary: this study will explore the safety, pharmacokinetics (pk) and pharmacodynamics (pd) of kp405 as a potential new treatment for parkinson's disease.


Eligibility criteria:
inclusion criteria: * healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ecg, cardiac holter monitoring and clinical laboratory evaluations. * clinical diagnosis of parkinson's disease meeting united kingdom brain bank criteria. exclusion criteria: * clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during screening as judged by the investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder), excluding parkinson's disease. * clinically significant, as judged by the investigator, neurologic disorder (other than parkinson's disease) including history of stroke or transient ischaemic attack within 12 months of screening, cognitive impairment, seizure within 5 years of screening or head trauma with loss of consciousness within 6 months of screening.